Respiratory mask

ABSTRACT

A respiratory mask is reduced in size to better fit patients with smaller faces by folding accordion folds of the mask. An adjustment member allows for selective folding of the accordion folds, thereby determining the size of the mask. The respiratory mask can thus be adjusted to fit both larger and smaller persons.

RELATED APPLICATIONS

This application is a continuation of application Ser. No. 10/766,413,filed Jan. 28, 2004, entitled “RESPIRATORY MASK”, which in turn is acontinuation-in-part of application Ser. No. 10/041,523, entitled“SIZE-ADJUSTABLE RESPIRATORY MASK” and filed Jan. 8, 2002, issued asU.S. Pat. No. 6,851,428, the entire contents of each of which are herebyincorporated by reference.

FIELD OF THE INVENTION

The present invention relates to respiratory masks used to administertreating gases or medications to patients. A representative treating gasis oxygen, and a representative medication is an aerosol for asthmatreatment.

BACKGROUND OF THE INVENTION

Hospitals and respiratory therapists administer treating gases toindividual patients by placing a respiratory mask over the patient'snose and mouth. The masks are supplied in standard sizes intended foradults and children. However, many adult patients have smaller facialdimensions such that the standard sizes do not fit properly, at bestmaking the mask uncomfortable and at worst leading to ineffectiveadministration of treating gases. In addition, many children havesmaller facial dimensions such that the standard mask sizes provided forchildren do not fit them. Hence, an adjustable-size respiratory mask isneeded to fit patients with smaller facial dimensions.

U.S. Pat. No. 4,657,010 discloses an adjustable face mask in which thebottom of the mask may be extended lengthwise by fastening a separateextension portion (lower portion 14) to the mask. The lower portion 14is provided with snap closures 42 that mate with eyelet holes 40 in theupper portion of the mask. The separate extension portion is awkward,and size adjustments cannot effectively be made while the mask is inplace over a patient's face. Most patient discomfort is caused when atoo large size mask covers their eyes and/or forehead, making the bottomportion size adjustment in this prior patent less helpful when trying tosolve the problems associated with over-sized respiratory masks.Moreover, the separate extension portion is more apt to be disconnectedor lost before or during use.

SUMMARY OF THE INVENTION

A size-adjustable respiratory mask has a plurality of accordion foldsformed between upper portion and a lower portion of the mask. Theaccordion folds have an open position which is most suited when the maskis to be used for an average or larger size adult, and a folded positionmost suited for when the mask is to be used for a smaller person. Anadjustment member is used to adjust the length of the mask by foldingthe accordion folds.

The accordion fold may be formed by one or more ribs connected by aflexible material, or by one or more tubes connected by a flexiblematerial. In the most preferred embodiment, the accordion fold is formedintegrally with the lower portion of the mask. The entire mask can beformed of a single piece of plastic material of constant thickness.

The mask may be constructed from one or more resilient plastic materialsthat are known as suitable for medical applications. Preferably, themask material is latex free and free of other known allergens.Preferably, the mask is constructed from one or more of the followingmaterials: thermoplastic resins, polyurethane resins, poly(vinylchloride), polypropylene, polyethylene, polystyrene, SURLYN® from E.I.DuPont de Nemours & Company, Inc., or other plastics. A particularlypreferred poly(vinyl chloride) is VM 1775 NT Clear 0001 from MaclinCompany of City of Industry, Calif.

DESCRIPTION OF THE FIGURES

FIG. 1 is a side elevational view of a respiratory mask according to afirst embodiment of the invention as sized for an average adult patient;

FIG. 2 is a fragmental front elevational view of the respiratory mask ofFIG. 1;

FIG. 3 is a side elevational view of a respiratory mask according to theinvention as adjusted in size for a smaller adult patient;

FIG. 4 is a fragmental front elevational view of the respiratory mask ofFIG. 3;

FIG. 5 is a cross-sectional view taken along line 5-5 of FIG. 2 showingsize-adjusting means as a button held within an opening in a strap;

FIG. 6 is a side elevational view of a respiratory mask according to asecond alternate embodiment of the invention;

FIG. 7 is a fragmental side elevational view of the respiratory mask ofFIG. 6;

FIG. 8 is a fragmental partial cross-sectional view showing a ballswivel joint connector engaged within the tubular inlet of a respiratorymask;

FIG. 9 is a fragmental side elevational view of a respiratory maskaccording to a third alternate embodiment of the invention;

FIG. 10 is a side elevational view of a respiratory mask according to afourth alternate embodiment of the invention;

FIG. 11 is a front elevational view of a respiratory mask according to afifth alternate embodiment;

FIG. 12 is a side elevational view of the respiratory mask of FIG. 11;and

FIG. 13 is an isolated view of an adjustment member of the respiratorymask of FIG. 11.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring first to FIG. 1, a respiratory mask 10 includes a mask portionfor covering the nose and mouth of a patient receiving a respiratorytreatment, such as oxygen or a medicative aerosol or vapor. The mask 10includes a tubular inlet 12 proximate the nose portion of the mask. Aconnector 14 is attached to the tubular inlet 12. A nebulizer (notshown) for delivering the respiratory treatment is in turn attached tothe connector 14. The mask 10 further defines one or more exhaust ports16, which are preferred when a mask is used for aerosol or vaportreatments. Head strap brackets 34 are attached to the lateral edges ofthe mask 10. One or more elastic head straps (not shown) are threadedthrough the brackets and wrap around the patient's head to hold the maskin place during treatment.

The mask 10 is provided with means for adjusting mask size. As shown inFIG. 1, the mask 10 is configured for a normal size adult male. The mask10 is provided with a deformable metal strap 18 attached by snaps 20.The metal strap 18 can be bent over the bridge of the patient's nose tohelp hold the mask in place during treatment.

Accordion folds 22 are provided in a parallel array at the top of thenose portion of the mask 10. Each accordion fold comprises a rib or tubeof stiffer material than the more resilient plastic material used toform the body of the mask. Each rib or tube is connected by lateral edgeto an adjacent rib or tube. When expanded, as shown in FIG. 1, the mask10 is of a size suitable for an adult male. Preferably, as shown in FIG.1, the accordion folds 22 are integral with the material forming the topportion of the mask 10.

A snap or button 24 is associated with each accordion fold 22. Thebuttons 24 are mounted on pins 26 to separate slightly the buttons fromthe edges of the accordion folds 22. A band 28 is connected to thedeformable metal strap 18 at its proximal end and defines one or moreopenings 30 at its distal end. The band 28 is formed from poly(vinylchloride) resin or plastic material. Preferably, the band 28 has athickness comparable to the distance of separation between the buttons24 and the accordion folds 22. As shown in FIGS. 1, 2 and 5, theuppermost button is held within the most distant hole in the band 28. Itwould also be possible to leave the distal portion of the band 28unattached to any button 24 associated with the accordion folds. In thepreferred embodiment, the accordion folds 22 can be expanded to a fullyopen position such that the mask is suitable for use by a larger adult.

The means for attaching the band 28 to a button 24 associated with anaccordion fold 22 is shown in FIG. 5. The openings 30, such as eyeletholes, have an inner diameter slightly smaller than the outer diameterof the buttons 24. Each opening or hole 30 in the band 28 can be snapfit over a button 24. The snap connection is not permanent, and anadjustment can be made readily by disconnecting the band from aparticular button and reattaching to another button.

Various size adjustments are possible. Referring next to FIGS. 3 and 4,the mask 10 is shown with the accordion folds 22 folded to a closedposition to reduce the mask size. In this embodiment, the third openingor hold in the band 28 engages the uppermost button, thus pulling thebutton and the associated accordion fold 22 tighter toward thedeformable strap 18 bridging the nose portion of the mask 10. With theaccordion folds 22 compressed and folded to a closed position, the mask10 is better suited for use by a smaller adult, such as a woman weighingunder 100 pounds, or by a teenager or child.

Preferably, the mask 10 is fabricated from nonallergenic materials knownto be suitable for contacting a patient's skin. Such materials include:thermoplastic resins, polyurethane resins, poly(vinyl chloride),polypropylene, polyethylene, polystyrene, SURLYN® from E.I. DuPont deNemours & Company, Inc., or other plastics. The preferred mask 10 isformed from a clear poly(vinyl chloride) resin or plastic (with athickness of about 0.020 inch) so that a respiratory technician orhealth care worker can observe the patient's face while treatments areadministered. A particularly preferred poly(vinyl chloride) is VM 1775NT Clear 0001 from Maclin Company of City of Industry, Calif.

A second preferred embodiment of the respiratory mask 10 is shown inFIG. 9, wherein the band 28 is provided with a hook strip 84 of a hookand loop fastener (such as a VELCRO® fastener) and the upper surface ofthe mask is provided with a loop strip 82. The size of the mask 10 isthen adjusted by compressing or folding the accordion folds 22 andcausing the hook strip 84 to contact the loop strip 82 to fasten theband 28 to the upper surface of the mask 10 to maintain the accordionfolds in a folded position.

A third preferred embodiment of the respiratory mask 50 is shown inFIGS. 6 and 7. Like parts are numbered with the same reference numeralsused in FIGS. 1-5. Rather than using accordion folds 22 (e.g., FIG. 1),the mask 50 incorporates a series of tear strips 36 that have tear tabs38 at one or both ends. Preferably, the tear strips 36 are integral withthe material forming the mask 50 and are separated by grooves 40 orother discontinuities in the thickness of the material. To reduce thesize of the mask 50, one of the tear strips 36 is pulled away from themask to separate the tear strip 36 and the upper portion of the mask 50above the strip from the remaining lower portion of the mask.

As an alternative to the grooves 40, perforations 42 (FIG. 7) may beprovided in the mask material to guide the tearing away of material toreduce the size of the mask 80.

The embodiment of the invention shown in FIGS. 1-5 permits variableadjustment of the mask size from larger to smaller. Moreover, once themask is adjusted to a smaller size, it may still be enlarged to theoriginal adult size or any size therebetween. The embodiments of theinvention shown in FIGS. 6 and 7, however, do not provide a means forreturning the mask to its original adult size following the sizeadjustment made by removing material from the top portion of the mask.Nevertheless, the embodiments of FIGS. 6 and 7 may have fabrication orcost advantages making them suitable for many applications.

Referring next to FIG. 10, an oxygen mask 90 has small respirationexhaust holes 92 formed in a pattern of concentric rings in each sidemask surface. Rather than a connector as shown in earlier maskembodiments, the oxygen mask 90 has a plug 94 attached to the tubularinlet 12. The plug 94 has a nipple to which is attached a separate tube96 for introducing oxygen to the patient. A series of angular taperedaccordion folds 98 are formed in the mask material above the noseportion, with each fold terminating at pivot point 97. When the folds 98are expanded, as shown in FIG. 10, the mask 90 is of a size suitable foran adult male. Preferably, as shown in FIG. 10, the accordion folds 98are integral with the material forming the top portion of the mask 90.

A snap or button 24 is associated with each accordion fold 98. Thebuttons 24 are mounted on pins 26 to separate slightly the buttons fromthe edges of the accordion folds 98. A band 28 is connected to thedeformable metal strap 18 at its proximal end and defines one or moreopenings 30 at its distal end. The band 28 is formed from poly(vinylchloride) resin or plastic material. Preferably, the band 28 has athickness comparable to the distance of separation between the buttons24 and the accordion folds 22. As shown in FIG. 10, the uppermost buttonis held within the most distant hole in the band 28. It would also bepossible to leave the distal portion of the band 28 unattached to anybutton 24 associated with the accordion folds. In the preferredembodiment, the accordion folds 22 can be expanded to a fully openposition such that the mask is suitable for use by a larger adult.

The size of the mask 90 is reduced to better fit the face of a smalleradult or a teenager or child by creasing or folding the mask materialalong the accordion folds 98. The folds are held in such creased orfolded position by inserting one or more of the buttons 24 into holes oropenings 30 in the band 28. Because the folds 98 have a tapered shapethat terminates at point 97, they can be folded to reduce the mask sizeyet still permit the contours of the outer edges of the mask to betterconform to the patient's face.

Each of the masks 10, 50, 80 and 90 may be modified also byincorporating a swivel joint connection as shown in FIG. 8. The inlettube 62 has an inner diameter d1 at its proximal end and an annulargroove 64 formed in its distal end. The inlet tube 62 usually isintegral with the respiratory mask, and generally depends from a centralportion of the mask that is proximate to a patient's nose when the maskis placed on a patient for respiratory treatment.

A connector 66 is snap fit into the inlet tube 62 during manufacture.The connector 66 has a tubular distal end and a ball joint 68 formed atits proximal end. The ball joint 68 defines an opening 72 such that theconnector communicates with the inlet tube to permit gases or treatingfluids to flow therethrough. The ball joint 68 is held within theannular groove 64 of the inlet tube 62. The ball joint 68 defines acenter point 70 about which the ball joint may swivel. The center point70 is positioned within the volume defined by the inlet tube between theuppermost edge of the annular groove and the lowermost edge of theannular groove. With this placement, the connector 66 swivels withrespect to the inlet tube 62 so that the distal end of the connector canbe moved away from a patient's face when a source tube for a gastreatment or a nebulizer is being connected. In addition, the swivelconnection permits the patient to adjust the angle of the source tubefor increased comfort.

A fifth preferred embodiment of a respiratory mask 110 is shown in FIGS.11-13. In FIGS. 11-13, like parts are numbered with similar referencenumerals to those used in FIGS. 1-5, preceded by a “1”. The respiratorymask 110 includes a mask portion for covering the nose and mouth of apatient receiving a respiratory treatment. The mask 110 includes atubular inlet 112 proximate to an upper or nose portion 113 of the mask110. A connector (not shown) may be attached to the tubular inlet 112. Anebulizer (not shown) for delivering the respiratory treatment is inturn attached to the connector. The mask 110 further defines one or moreexhaust ports 116, which are preferred when the mask 110 is used foraerosol or vapor treatments. Head strap brackets 134 are attached to thelateral edges on either side of the mask 110. One or more elastic headstraps (not shown) may be threaded through the brackets 134 and wrappedaround the patient's head to hold the mask 110 in place duringtreatment.

As in the embodiment shown in FIGS. 1-5, the mask 110 is provided with adeformable metal strap 118 attached by snaps 120. The metal strap 118can be bent over the bridge of the patient's nose to help hold the mask110 in place during treatment. The metal strap 118 can be made from, forexample, aluminum.

The size of the mask 110 is adjustable by compression or expansion ofaccordion folds 122 arranged in a parallel array below the upper portion113 of the mask 110. An adjustment member 150 is used to adjust thedegree to which the accordion folds 122 are compressed. In this way thesize of the mask 110 is adjusted along a vertical extent of the mask110. When fully expanded, as shown in FIGS. 11 and 12, the mask 110 maybe of a size suitable for an adult male. Compressing the accordion folds122 adjusts the size of the mask 110 to fit smaller persons.

Each accordion fold 122 may comprise a rib or tube of stiffer materialthan the more resilient plastic material used to form the body of themask 110. In this embodiment, each rib or tube is connected by a lateraledge to an adjacent rib or tube. Preferably, as shown in FIGS. 11 and12, the accordion folds 122 are integral with the material forming theremainder of the mask 110.

The accordion folds 122 may also be made as a single continuous piecewith and from the same injection-molded material as the remainder of themask 110. The entire mask 110 may be formed from, for example, a singlethickness of plastic material in order to simplify production. Theaccordion shape of the folds 122 allows for adjustment of mask size.

The adjustment member 150 is shown in detail in FIG. 13. Referring toFIGS. 11-13, the adjustment member 150 comprises a first bracket 152 anda second bracket 154 that is movable relative to the first bracket 152.The relative movement between the first and second brackets 152, 154provides adjustment of the size of the mask 110 in the verticaldirection.

The first bracket 152 includes a band portion 153 that is fixedlymounted below the nose portion 113, and is attached at each end toadjusting bars 158. The second bracket 154 includes a band portion 155that is fixedly attached at a bottom portion 130 of the mask 110 belowthe accordion folds 122, and includes slots 160 for receiving theadjusting bars 158. Locking members 162 are pivotably mounted on thesecond bracket 154. The locking members 162 have proximal ends thatselectively engage teeth 166 on the adjusting bars 158. The undersidesof the teeth 166 slope upwardly so that the bottom portion 130 of themask 110 can be easily pushed upwardly until a desired tooth 166 isengaged by the proximal end of a locking member, attaining the desiredsize of the mask 110. The distal ends of the locking members 162 can bepivoted inwardly (toward the mask as indicated by arrows in FIG. 13) inorder to disengage the proximal ends of the locking members 162 from theteeth 166. The bottom mask portion 130 can then be lowered by extendingthe accordion members 122, thereby increasing the length of the mask110. Alternatively, the bottom mask portion 130 can be raised, such asin the direction of arrow A in FIG. 12 to shorten the length of the mask110.

Referring to FIG. 13, the band portion 155 of bracket 154 is shown in afirst open position wherein the accordion folds would be extended orfully open. The band portion 155 is shown in phantom outline in a secondmore closed position wherein the accordion folds would be partly foldedor compressed so that the mask would have a smaller size to fit asmaller sized patient. The locking members 162 are shown with proximalends engaged to the teeth 166 when in the first open position, and areshown in phantom outline as pivoting inwardly to disengage the proximalends from the teeth 166 when the band portion is moved upwardly to causethe accordion folds to be partly folded or compressed to reduce the masksize.

Preferably, the brackets 152, 154 are attached to the mask at one ormore target protrusions or posts 170 extending outwardly from the mask110. For example, three posts 170 can extend from the upper portion 113of the mask 110 to mate with small cavities (not shown) in the bandportion 153 and attach the bracket 152, and three posts 170 can be usedto attach the band portion 155 of bracket 154 to bottom mask portion130. The posts can be distributed across the width of the upper portion113 and bottom portion 130 of the mask 110. The brackets 152, 154 slideover the posts in a manner similar to the attachment of an aluminum noseclip 118 to snaps 120. Alternatively, adhesive or glue may be usedsolely or in combination with protrusions or posts 170 to secure thebrackets 152, 154 to the mask 110.

The first and second brackets 152, 154 can be made as, for example,integral molded plastic parts. Rigid but flexible plastics, such as ABSplastic or polypropylene are preferable.

The size of the mask 110 may also be adjusted using a button and snaparrangement as illustrated in FIGS. 1-5. A hook and loop fastenerarrangement, as illustrated in FIGS. 6-9, or a band arrangement as shownin FIG. 10 may also be used. If any of these arrangements are used inthe embodiment of FIGS. 10 and 11, the attachment points for theadjusting arrangement may be located at the bottom of the mask 110 andbelow the nose portion 113.

The mask 110 may be modified by incorporating a swivel joint connectionas shown in FIG. 8.

The mask 110 illustrated in FIGS. 11-13 includes two exhaust ports 116,and has the form of an “aerosol” mask. Aerosol masks are used todeliver, for example, medicines to the patient in aerosol form from anebulizer. The exhausts ports 116 allow the aerosol and gas in the mask110 to escape.

In an alternative embodiment (not illustrated), the mask 110 has theform of a “partial rebreather” mask. In this embodiment, the exhaustports 116 are replaced by a pattern of a plurality of small apertures oneach side of the mask 110, similar to the exhaust holes 92 illustratedin FIG. 10. A reservoir bag, filled with oxygen, is connected to thetubular inlet 112. An exhalation port is located between the reservoirbag, as part of the bag assembly, and the mask 110.

In yet another alternative embodiment (not illustrated), the mask 110has the form of a “nonrebreather” mask. In this embodiment, the exhaustports 116 are replaced by a pattern of a plurality of apertures on eachside of the mask 110, similar to the exhaust holes 92 illustrated inFIG. 10. The apertures can be arranged in a circular pattern, with apost in the center each pattern. Each post holds a one-way flap. When apatient inhales, the flaps close against the apertures, preventingoutside air from entering the mask 110 through the apertures. The flappushes away from the apertures when the patient exhales, allowing gasesin the mask 110 to escape. An exhalation port is located between thereservoir bag and the mask 110.

In yet another alternative embodiment (not illustrated), the mask 110has the form of a “venturi” mask. The venturi mask has exhaust ports orapertures, similar to the ports 116 shown in FIGS. 11-13, and isconnected to a tube at the tubular inlet 112. A venturi is located inthe tube, and adjustment of airflow through the venturi allows for veryprecise levels of oxygen to be provided to the patient.

In still yet another alternative embodiment (not illustrated), the mask110 has the form of a “simple” mask. The simple mask has a plurality ofsmall apertures on each side of the mask 110, similar to the exhaustholes 92 illustrated in FIG. 10. In this embodiment, the mask 110 isconnected to an adapter at the tubular inlet 112, which is connected tooxygen tubing.

Preferably, the mask embodiments disclosed in this specification arefabricated from nonallergenic materials known to be suitable forcontacting a patient's skin. Such materials include: thermoplasticresins, polyurethane resins, poly(vinyl chloride), polypropylene,polyethylene, polystyrene, SURLYN® from E.I. DuPont de Nemours &Company, Inc., or other plastics.

While specific embodiments of the invention have been described andillustrated, such embodiments should be considered illustrative of theinvention only and not as limiting the invention as construed inaccordance with the accompanying claims.

1. A respiratory mask, comprising: an upper portion defining an uppermask edge; a bottom portion defining a bottom mask edge, such that themask has a first vertical length between the upper mask edge and bottommask edge; a plurality of accordion folds extending across a width ofthe mask between the upper portion and the bottom portion; and anadjustment member attached at the bottom portion of the mask, whereinthe accordion folds are compressible from an open position of the firstvertical length of the mask to a closed compressed position of a secondvertical length of the mask that is reduced from the first verticallength by adjustment of the adjustment member that maintains the foldsin the closed compressed position to reduce mask size.
 2. The mask ofclaim 1, wherein the accordion folds are adjustable from an openposition for a first mask size to a closed position for a second masksize.
 3. The mask of claim 1, further comprising: a deformable strapbridging the upper portion of the mask, wherein the deformable strap isformed of bendable material and is bendable to conform to the contoursof a patient's nose to hold the mask in place.
 4. The mask of claim 1,wherein the accordion folds are formed by one or more ribs connected bya flexible material.
 5. The mask of claim 1, wherein the accordion foldsare formed integrally with the upper and bottom portions of the mask. 6.The mask of claim 1, wherein the adjustment member comprises: one of abutton and snap arrangement, a hook and loop fastener arrangement, and aband adjustment arrangement.
 7. The mask of claim 1, wherein the mask isformed from a material selected from the group consisting of:thermoplastic resins, polyurethane resins, poly(vinyl chloride),polypropylene, polystyrene and polyethylene.
 8. The mask of claim 1,further comprising: at least one exhaust port or a plurality ofapertures disposed in the upper portion of the mask.
 9. The mask ofclaim 9, further comprising: a tubular inlet disposed at the bottom ofthe upper portion of the mask.
 10. The mask of claim 1, wherein theupper portion, the bottom portion and the accordion folds comprise acontinuous piece of material.
 11. The mask of claim 11, wherein thecontinuous piece of material forming the upper and bottom portions andthe accordion folds is of substantially constant thickness.
 12. A methodof adjusting a respiratory mask, comprising: providing a mask comprisingan upper portion defining an upper mask edge, a bottom portion defininga bottom mask edge, such that the mask has a first vertical lengthbetween the upper mask edge and bottom mask edge, and a plurality ofaccordion folds extending across a width of the mask between the upperportion and the bottom portion; and adjusting an adjustment member tomaintain the accordion folds in a desired unfolded or folded position soas to obtain a desired length along the vertical extent of the mask thatis the first vertical length or a length reduced from the first verticallength.
 13. The method of claim 13, wherein adjusting the adjustmentmember comprises: adjusting one of a button and snap arrangement, a hookand loop fastener arrangement, and a band adjustment arrangement. 14.The method of claim 13, wherein the accordion folds comprise one or moreribs connected by a flexible material.
 15. The method of claim 13,wherein the upper portion, the bottom portion and the accordion foldscomprise a continuous piece of material of substantially constantthickness.